Medications & Supplements/Prescription Drugs

Lohxa LLC: Chlorhexidine Gluconate Oral Rinse Recalled for Bacterial Contamination

Agency Publication Date: November 30, 2020

Summary

Lohxa LLC is recalling 329 cartons (approximately 16,450 unit dose cups) of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, which is a prescription mouthwash used to treat gingivitis. The product was found to be contaminated with Burkholderia lata bacteria during manufacturing. This recall affects 15 mL unit dose cups distributed to medical facilities in Florida and New York. Consumers should immediately stop using the product and consult a healthcare provider, especially if they have underlying health conditions.

Risk

The mouthwash is contaminated with Burkholderia lata, a bacteria that can cause severe or life-threatening infections in patients with weakened immune systems or underlying lung conditions like cystic fibrosis.

What You Should Do

Identify the product: Look for 15 mL unit dose cups of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, which may be identified by NDC 70166-027-15 and barcode 7016602715.
Check the lot and expiration: Look for lot T09101A (Exp 01/2021); T08292A or T10011A (Exp 02/2021); or T10223A or M10193A (Exp 03/2021).
If you possess any of these affected lots, stop using them immediately and do not distribute them to patients.
Contact your healthcare provider or pharmacist immediately for guidance if you have used this product or provided it to a patient.
Return any unused product to the place of purchase or pharmacy to receive a refund and contact Lohxa LLC in Worcester, MA for further instructions.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider guidance and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free (15 mL unit dose cups)

Model:

NDC 70166-027-15

barcode 7016602715

Lot Numbers:

T09101A (Exp 01/2021)

T08292A (Exp 02/2021)

T10011A (Exp 02/2021)

T10223A (Exp 03/2021)

M10193A (Exp 03/2021)

Date Ranges: Exp 01/2021, Exp 02/2021, Exp 03/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86717

Status: Resolved

Manufacturer: Lohxa LLC

Sold By: medical facilities

Manufactured In: United States

Units Affected: 329 cartons

Distributed To: Florida, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify the product: Look for 15 mL unit dose cups of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, which may be identified by NDC 70166-027-15 and barcode 7016602715.

Check the lot and expiration: Look for lot T09101A (Exp 01/2021); T08292A or T10011A (Exp 02/2021); or T10223A or M10193A (Exp 03/2021).

If you possess any of these affected lots, stop using them immediately and do not distribute them to patients.

Contact your healthcare provider or pharmacist immediately for guidance if you have used this product or provided it to a patient.

Return any unused product to the place of purchase or pharmacy to receive a refund and contact Lohxa LLC in Worcester, MA for further instructions.

For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free (15 mL unit dose cups)

Model:

NDC 70166-027-15

barcode 7016602715

Lot Numbers:

T09101A (Exp 01/2021)

T08292A (Exp 02/2021)

T10011A (Exp 02/2021)

T10223A (Exp 03/2021)

M10193A (Exp 03/2021)

Date Ranges: Exp 01/2021, Exp 02/2021, Exp 03/2021